Managed Access Program Specialist

Main Responsibilities

The Managed Access Program (MAP) Specialist’s primary role is to identify the “Managed Access” requests belonging to Sanofi or Affiliate from the Sanofi or Affiliate Portal and to maintain the tracking of these requests through the review process and until the decision is communicated to the requesting physician. The position reports to the in coordination with the M&OE operations and Governance Lead. The role is the Owner of case submission process including verifying completeness of documentation, communication with Global Medical, recording decisions and country follow-up while ensuring compliance to MAP SOP.

This Includes But Is Not Limited To The Following

• Process all the received MAP requests as per the agreed TAT and quality.
• Store and manage documentation of all processed requests.
• Supporting internal audits for MAP process and documents.
• Supporting queries related to MAP requests from HCP or Local Medical teams.
• Support Global MAP team in projects execution.
• Comply with all quality practices as per SOP and notify if any deviation.
• Support MAP requests go through MRPTC processes wherever applicable.
• Upload and organize all relevant documentation within SharePoint site and ensure audit-ready environment.
• Process Pre-Registration Import License and Restricted Import License
• Adherence to all the TAT & Quality check procedures
• Support in establishing a new process or system by closely working with Governance and/or Operations Lead
• Supports affiliates for MAP requests management process transition or requests by collaborating with Operations Lead and affiliate stakeholders.
• People: (1) Primary point of contact for local medical teams globally for MAP questions, case submissions, process inquiries etc.;(2) Responds to internal and external inquiries regarding Sanofi or Affiliate MAP (3) Liaise and coordinate with colleagues from Global & Local medical teams, Project Management team, and Quality; (4) Provide reporting and MAP program updates (as needed) to global medical teams (5) Maintain Global contacts lists for MAP communications
• Performance: (1) Ensure deliverables meet the required timelines, quality targets and adhere to the compliance requirements;(2) Managing MAP requests related documents timely storage and retrieval; (3) Escalating MAP requests to MRPTC process and managing the documentation (4) Timely sharing the MRPTC meeting notes to all the relevant stakeholders with appropriate actions; (5) Adhering to affiliate process while processing affiliate requests
• Process: (1) Receive and track all MAP requests for assigned portfolio ensuring evaluation and response to requesting physician are completed in a timely manner; (2) Upload and organize all relevant documentation within SharePoint site and ensure audit-ready environment; (3) Identify best practices and operational efficiencies within assigned MAP portfolio; (4) Participate in cross-functional Global MAP meetings to understand and anticipate pipeline products that would be eligible for MAP; (5) Assist medical teams to liaise with Global and/or MRP-TC secretary for all requests that require escalation; (6) Owner of MAP documentation including criteria, application forms, decision letters and training manuals; Partnering with Medical, Legal and Compliance teams to ensure documentation meets patient privacy requirements and disease specific guidelines; (7) Prepare and provide documentation to support audit-related activities to ensure compliance with Sanofi policies & procedures at the local, regional and global level.
• Stakeholders: (1) MAP Operations & Efficiency lead; (2) MAP Governance Leads; (3) Local medical teams; (4) Quality; (5) MRPTC team; (6) Affiliates (7) CMO office
  
  

About You

Experience: 5+ years of experience in a pharmaceutical industry with Access management or clinical study management, project management and Medical Operations Activities.

Soft skills: Strong communication skills (written & verbal), Strong administrative and organization skills

Technical skills: Proficient MS office skills. Service Now & PowerBI will be a plus.

Education: Bachelor/Higher degree in science.

Languages: Excellent knowledge of English language (spoken and written).

Pursue Progress, discover Extraordinary

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